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Cenobamate for Epilepsy
Study Summary
This trial will test the safety and tolerability of cenobamate in children with partial-onset (focal) seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 1345 Patients • NCT02535091Trial Design
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Who is running the clinical trial?
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- I've used emergency anxiety medication more than once in the last month.I have been diagnosed with Familial Short QT Syndrome.I have a rare hereditary sugar intolerance condition.I only have seizures that don't affect my movement or are generalized.I have never had liver or blood problems from taking felbamate.You have a heart condition that shows up on an ECG test, like a prolonged or shortened QT interval.I haven't taken vigabatrin for 5 months and my eye test after stopping it was normal.I have been diagnosed with epilepsy that starts in one area of my brain for over a year.I have been taking felbamate for at least a year and have been on a stable dose for the last 60 days.I am scheduled for epilepsy surgery within 6 months, or I had an unsuccessful epilepsy surgery before.My liver is generally healthy or has stable enzyme levels not more than 3 times the normal limit.You have had a severe allergic reaction to a medication in the past that caused a serious skin condition or required hospitalization.You have stopped taking a medication in the past because of a non-serious allergic reaction more than once.You have had a rash caused by a specific type of medication that affected your eyes or mucous membranes.I am between 2 and 17 years old and can give consent.I weigh at least 22 pounds.If you are new to Study YKP3089C040, you must have had at least one specific type of seizure in the 28-day period before starting the study.I am on 1 to 3 stable epilepsy drugs and not counting a VNS, which has also been stable.I have never taken cenobamate or am allergic to its ingredients.I do not have any major health issues that could affect my safety in the study.I was hospitalized for a severe seizure within the last 6 months.I am not pregnant or breastfeeding.I have had pseudo-seizures in the last 2 years.You have a low white blood cell count or neutrophil count, which shows that you have a significant blood-related illness.I am taking felbamate as part of my treatment.You have had thoughts about wanting to harm yourself in the past 6 months.My kidney function is moderately or severely reduced.My condition involves worsening brain or nerve disease or a growing brain tumor.I haven't had a VNS implant or its settings changed within the last 5 months.You can follow a ketogenic diet as long as you've been doing it for at least 30 days before the first visit and will continue to do so during the study.
- Group 1: 2 to <4 years old
- Group 2: 12 to < 18 year olds
- Group 3: 6 to <12 years old
- Group 4: 4 to <6 years old
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the requirements to be eligible for this test?
"The team conducting this trial is looking for 140 participants that have gelastic epilepsy and are between 2 and 18 years old."
Are octogenarians able to join this research project?
"Children aged 2 to 18 years-old are eligible for this clinical trial, with 47 similar studies available for patients under 18 and 78 for those over 65."
Are there any other instances in the medical literature of Xcopri being used?
"At the moment, there are 5 independent studies being conducted for Xcopri. Out of those 5, 4 are in Phase 3. Although the majority of these tests are being done in Memphis, Tennessee, there are 148 other locations where these trials are running."
How many research participants are included in this experiment?
"Recruitment for this clinical trial is currently paused. The study was originally posted on January 14th, 2022 with the last update on October 11th, 2022. However, if you are looking for other studies, there are 102 studies actively admitting participants with gelastic epilepsy and 5 trials for Xcopri actively admitting patients."
Are research participants still being recruited for this project?
"Unfortunately, this study is no longer admitting patients. The trial was first posted on 1/14/2022 and saw its last update on 10/11/2022. If you are interested in other trials, there are 102 trials for gelastic epilepsy and 5 trials for Xcopri that are still admitting patients."
In how many settings is this research project being conducted?
"Prior mentioned, this study is enrolling patients at Duke University Hospital in Durham, North carolina, Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland, and Phoenix Children's Hospital in Phoenix, Arizona. In addition, there are 5 other recruitment centres."
Could you please outline the risks associated with taking Xcopri?
"There is existing clinical evidence for the efficacy of Xcopri as well as data from multiple rounds of safety trials, so it received a score of 3."
Do we have any previous case studies to compare this to?
"SK Life Science, Inc. first conducted a Phase 3 clinical trial for Xcopri in 152 patients back in 2018. Since then, there have been 7 completed trials across 10 countries and 49 cities."
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